FINAL REJECTION
Receipt is acknowledged of Applicants' Amendments and Remarks, filed Aug. 12, 2026.
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The rejections and/or objections set forth below are either maintained or newly applied, and constitute the complete set presently applied to the instant claims.
STATUS OF THE CLAIMS
Claims 3-5, 8-17, 21-35, 37-44, 46-52, 54-61, 63-68, 70-72, 74-77, 79-87, 89-95, 97-99, 101, 103-257, 260, and 261 are canceled.
Claim 1, 53, 102, and 258 have been amended and incorporate no new matter.
No new claims have been added.
Claims 6, 36, 45, 62, 69, 73, 96, 100, and 259 stand withdrawn as drawn to nonelected inventions and/or species.
Thus, claims 1, 2, 7, 18-20, 53, 78, 88, 102, and 258 now represent all claims currently pending and under consideration.
INFORMATION DISCLOSURE STATEMENT
No new Information Disclosure Statements (IDS) have been submitted.
RESPONSE TO AMENDMENTS
The amendments to the claims overcome the rejections under 35 U.S.C. § 112(b) and 35 U.S.C. § 103. Therefore, these rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Gucky et al., as set forth below.
NEW REJECTIONS
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 2, 7, 18-20, 53, 78, 88, 102, and 258 are rejected under 35 U.S.C. 103 as being unpatentable over Gucky et al. (US Pub. 2015/0368248, of record).
Gucky et al. disclose as a preferred embodiment the compound [9-cyclopentyl-2-(piperazin-1-yl)-(9H)purine-6-yl]-(4-pyrazol-1-yl-benzyl)amine (para. [0053], p. 6, right col., lines 31-32), having the structural formula shown below:
Compound of
Gucky et al.
Claimed compound (I-27)
(Claim 102)
Claimed Formula (I)
(Claim 1)
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which reads on formula (I) as recited by claims 1, 2, 7, 18-20, 53, 78, and 88, and compound (I-27) as recited by claim 102, to the extent that:
X1 and X3 are each CH, and X2 is C substituted by pyrazole;
R1, R2, R3, R4, and R5 are each hydrogen;
R6 is unsubstituted 3- to 12-membered carbocycle (cyclopentyl); and
R7 and R8 taken together with the nitrogen to which they are attached form ring B, which
is an unsubstituted 3- to 12-membered heterocycle (piperazine).
The compounds of Gucky et al. are disclosed in pharmaceutical compositions together with a pharmaceutically acceptable carrier (claims 8-9), as recited by claim 258.
The compounds of Gucky et al. are disclosed as inhibitors of cyclin-dependent kinases (CDKs), including CDK 5, 7, and 9 (para. [0050]; Examples 31 and 40; Fig. 7), useful in methods of treating cancer (para. [0007]; claims 6-7).
Gucky et al. differs from claimed formula (I) as recited by claim 1, and compound (I-27) as recited by claim 102, in that [9-cyclopentyl-2-(piperazin-1-yl)-(9H)purine-6-yl]-(4-pyrazol-1-yl-benzyl)amine is a positional isomer of the claimed compounds, wherein the pyrazole (ring A) substitutes the phenyl ring in para position rather than ortho.
However, the compounds of Gucky et al. are disclosed to have the same mechanism and utility as the claimed compounds, as inhibitors of cyclin-dependent kinases (CDKs) with utility in methods of treating cancer (paras. [0007], [0050], Examples 31, 35, and 40; claims 6-7).
Therefore, it would have been predictable to one of ordinary skill in the art as of the filing date to modify [9-cyclopentyl-2-(piperazin-1-yl)-(9H)purine-6-yl]-(4-pyrazol-1-yl-benzyl)amine of Gucky et al. by changing the position of the pyrazole ring from para to ortho with a reasonable expectation of success, because positional isomers are prima facie obvious even in the absence of a teaching to modify.
As recognized by MPEP § 2144.09, compounds which are positional isomers (i.e., having the same radicals in physically different positions on the same nucleus) are generally of sufficiently close structural similarity that there is a presumed expectation that they possess the same properties. This expectation is then deemed the motivation for preparing the position isomers. See In re Wilder, 563 F.2d 457 (CCPA 1977). Compounds that differ only in the placement of substituents in a ring system are not patentable absent a showing of unexpected properties. See In Re Papesch, 315 F.2d 381 (CCPA 1963); see also MPEP § 2144.09 (I).
RESPONSE TO ARGUMENTS
Applicant's arguments filed Aug. 12, 2026 have been fully considered but they are not persuasive.
With respect to the compounds of Gucky et al., Applicant contends that moving the pyrazole from the para position to the ortho position is not merely a simple positional change, as it changes the spatial orientation of the respective substituents relative to the core and thereby affects the properties of the compound.
However, Applicant has provided no evidence to support this assertion.
As recognized by MPEP § 2145(I), the arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997) (“An assertion of what seems to follow from common experience is just attorney argument and not the kind of factual evidence that is required to rebut a prima facie case of obviousness.”). See MPEP § 716.01(c) for examples of attorney statements which are not evidence and which must be supported by an appropriate affidavit or declaration.
With respect to technical effects, Applicant asserts that the compound recited in independent claim 1 exhibits good inhibitory activity against CDK7 (Remarks, p. 20).
However, the compounds of Gucky et al. are disclosed to have the same mechanism and utility as the claimed compounds, as inhibitors of cyclin-dependent kinases (CDKs), useful in methods of treating cancer (see, e.g., paras. [0007], [0050], Examples 31, 35, and 40; claims 6-7). Therefore, the activity of the claimed compounds as CDK7 inhibitors is expected.
As recognized by MPEP §716.02(c)(II), "[e]xpected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof.” In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967).
CONCLUSION
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
CORRESPONDENCE
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA E. TOWNSLEY whose telephone number is 571-270-7672. The examiner can normally be reached on Mon-Fri from 10:00 am to 6:00 pm (EST). If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jeff S. Lundgren, can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARA E. TOWNSLEY/Examiner, Art Unit 1629
